AMSure® Sterile Water for lrrigation USP 1000 mL

Basic Information

• Brand Name: AMSure® Sterile Water for lrrigation USP 1000 mL
• Primary DI: 00704411020533
• Version / Model: 1
• Catalog Number: AS-6491
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-05
• Public Version: 1
• Public Version Date: 2025-12-15
• Public Version Status: New
• Public Device Record Key: da834635-e13e-4e4a-9a7e-3f9bd7efc386

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
62659	Wound irrigation sterile water	A fluid consisting of sterile water (no other compounds/additives) intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is typically provided in an appropriate container. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40704411020531	GS1	Case	9	In Commercial Distribution
Primary	00704411020533	GS1

Premarket Submissions

Submission Number	Supplement Number
K083042	000